Description du poste
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. About the role: As an Engineer Commissioning & Qualification, you will play an important role in ensuring that equipment, utilities and computerized systems across our Thörishaus site are commissioned, qualified and validated in a compliant and robust way. Working closely with cross-functional teams and external partners, you will act as a primary technical point of contact for C&Q topics and help ensure that our systems meet GMP and regulatory requirements from day one. Your responsibilities: - Project Execution: Plan, coordinate, and execute assigned commissioning, qualification, and validation activities (IQ, OQ, PQ) in alignment with project schedules and milestones - Direct Involvement in Qualifications: Personally conduct and supervise the execution of qualification tests to guarantee compliance with design specifications and regulatory requirements - Documentation Management: Prepare, review, and maintain high-quality C&Q documentation such as protocols, reports, deviation records, and traceability matrices - Regulatory Compliance: Ensure all C&Q activities comply with applicable GMP, GxP, and regulatory requirements (e.g. EU GMP, FDA) and are always inspection-ready - Continuous Improvement: Contribute to the continuous improvement of C&Q processes, templates, and standards to enhance efficiency, compliance, and inspection readiness - Cross-functional Collaboration: Collaborate with Engineering, Quality, Manufacturing, - Automation, and external suppliers to support effective and aligned execution of C&Q activities About you: - Degree (university or university of appl